ABSTRACT
RESUMEN Para potenciar la inmunidad en personas con deterioro gradual del sistema inmune, causado por el envejecimiento o por padecer diferentes comorbilidades, el Grupo de las Industrias Biotecnológica y Farmacéutica de Cuba (BioCubaFarma) ha introducido el producto Biomodulina T. Este se ha utilizado, además, como parte del protocolo de prevención y para el tratamiento de pacientes positivos al SARS-CoV-2. La inmunidad dependiente del timo, incluida la inmunidad de células T y la producción de anticuerpos, disminuye con el tamaño del órgano en los adultos, lo que se conoce como "inmunosenescencia". La Biomodulina T es un extracto diafiltrado de timo de ternera; tiene una acción citorrestauradora e inmunomoduladora, que ha demostrado su eficacia en diferentes grupos de riesgo, dentro de los cuales los ancianos ocupan un lugar especial. En la actual situación epidemiológica nacional e internacional su inclusión en los protocolos de actuación es clave. El uso de este medicamento en un grupo vulnerable, como los ancianos, representa un horizonte esperanzador en tanto se avanza en la producción de vacunas nacionales que sean seguras y eficaces (AU).
ABSTRACT To boost immunity in people with gradual deterioration of the immune system, caused by aging or suffering from different comorbidities, the Group of the Biotechnology and Pharmaceutical Industries of Cuba (Biotechnology Farma) has introduced the product Biomodulin T. This has also been used as part of the prevention protocol and for the treatment of patients positive to SARS-CoV-2. Thymus-dependent immunity, including T-cell immunity and antibody production, decreases with organ size in adults, which is known as "immunosenescence." Biomodulin T is a diafiltered extract of veal thymus; it has a cytorestaurative and immunomodulatory action, which has demonstrated its effectiveness in different risk groups, within which elder people occupy a special place. In the current national and international epidemiological situation its inclusion in the protocols of action is significant. The use of this medication in a vulnerable group, such as elder people, represents a hopeful horizon as progress is made in the production of safe and effective national vaccines (AU).
Subject(s)
Humans , Male , Female , Coronavirus Infections/drug therapy , Drug Development/classification , Therapeutics/methods , Drug Therapy/trends , Drug Development/methods , Drug Development/organization & administration , Immunity/drug effectsABSTRACT
Early prediction of elimination pathways for new chemical entities can have a profound impact on drug discovery programs. The recently proposed Extended Clearance Classification System (ECCS) is a step in the right direction, providing a framework to help identify the major elimination pathway of a drug. A list of 42 Amgen small molecules was evaluated against the ECCS framework to assess its performance in retrospectively predicting their major elimination pathway. Here, we present a critical analysis of the chemical space defined by the ECCS framework with the aim of identifying its applicability and constraints. This evaluation highlights the critical need for periodic review and revision of ECCS, given that target constraints are moving molecules away from the traditional 'drug-like' physicochemical space.
Subject(s)
Drug Discovery , Drug Elimination Routes , Pharmacokinetics , Biochemical Phenomena , Biological Availability , Biometry/methods , Drug Development/classification , Drug Development/methods , Drug Discovery/methods , Drug Discovery/trends , Humans , Metabolic Clearance Rate , Molecular Weight , Permeability , Principal Component AnalysisABSTRACT
Fewer new medicines have become available to patients during the last decades. Clinical efficacy failures in late-phase development have been identified as a common cause of this decline. Improved ways to ensure early selection of the right drug targets when it comes to efficacy is therefore a highly desirable goal. The aim of this work was to develop a strategy to facilitate selection of novel targets already in the discovery phase that later on in clinical development would demonstrate efficacy. A cross-functional team at AstraZeneca with extensive experience in drug discovery and development participated in several workshops to identify the critical elements that contribute to building human target validation [(HTV); the relevance of the target from a human perspective]. The elements were consolidated into a 10-point HTV classification system that was ranked from lowest to highest in terms of perceived impact on future clinical efficacy. Using 50 years of legacy research and development data, the ability of the 10-point HTV classification to predict future clinical efficacy was evaluated. Drug targets were classified as having low, medium, or high HTV at the time of candidate drug selection. Comparing this HTV classification with later clinical development efficacy data showed that HTV classification was highly predictive of future clinical efficacy success. This new strategy for HTV assessment provides a novel approach to early prediction of clinical efficacy and a better understanding of portfolio risk.
